RBC Dominion Securities has initiated coverage of ProMetic Life Sciences (OTCQX:PFSCF; TSX:PLI) with an “outperform, speculative risk” rating and price target of $3.50. The stock closed at $2.20 on Wednesday.

Analyst Douglas Miehm writes that for more than 25 years, ProMetic has helped other biopharmaceutical companies bring drugs to market with its bioseparation technology, and it is now leveraging that expertise to develop rare plasma-derived products of its own.

“A small molecule program, PBI-4050, is in the early stages but has shown impressive anti-fibrotic activity in liver/lung diseases and may have blockbuster potential,” he added.

Roughly three-quarters of Mr. Miehm’s valuation comes from the base bioseparation business and the plasma protein platform, with relatively low development risks, and the remaining portion is derived from a high risk/reward anti-fibrotic agent.

PBI-4050 is an oral agent developed internally that has demonstrated impressive anti-fibrotic activity in a broad range of organs, including the kidney, liver, lungs and heart.

A Phase 2 study for idiopathic pulmonary fibrosis is under way and a Phase 2/3 trial is anticipated to start in the first half of 2016. Two other Phase 2 trials for metabolic syndrome and chronic kidney disease associated with diabetes are set to begin in the second half this year.

“With several development programs under way, trial news flow and regulatory filings are anticipated over the next 12-to-24 months,” Mr. Miehm said. “In order to address multiple global markets and as clinical programs mature, we are also anticipating partnership (commercial/manufacturing) deals to be announced.”

H.C. Wainwright has launched coverage of Semler Scientific (NASDAQ:SMLR) with a “buy” rating and a 12-month price target of $8. The stock closed at $3.20 on Tuesday.

Semler is a medical diagnostics company that is marketing a patented device for the risk assessment of peripheral arterial disease (PAD) and other vascular conditions. Known as FloChec, the device allows a four-minute blood flow test to be conducted in the offices of internists and primary care physicians.

Insurance payers and physicians are incentivized to identify patients with vascular diseases since the Affordable Care Act led to a shift in government-sponsored health care from fee-for-service programs to capitated programs, where the government pays a fixed amount per patient, with a higher payment for patients with chronic diseases.

“Semler is well-positioned to benefit from this health care trend as the FloChec test provides an effective, easy-to-use, and cost-saving approach to health care providers in diagnosing adult individuals who may be asymptomatic but nevertheless at risk of developing PAD,” writes analyst Yi Chen.

Considering the revenue growth trend in the past quarters, Mr. Chen figures the company could continue to ramp up sales and achieve profitability in 2017.

He said Semler currently trades at an enterprise value of roughly $15-million, “which we believe is undervalued given that its product is already generating revenue and has considerable market potential.”

Data on Amarantus Diagnostics’ next generation sequencing molecular diagnostic test for multiple sclerosis, MSPrecise, has been published in the Elsevier journal, GENE.

MSPrecise is a proprietary next-generation DNA sequencing assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS). A blood-based version of the test is in development.

“Given the early misdiagnoses that often occur with multiple sclerosis, physicians have an increasing need for new methods to accurately diagnose their patients,” Colin Bier, chief development officer of Amarantus Diagnostics, a unit of Amarantus BioScience Holdings (OTCQX:AMBS), said in a statement.

In the 2013 study reported in GENE, there was an overall MSPrecise accuracy of 84% in identifying RRMS patients or patients that will develop RRMS, which represents a huge benefit to physicians, Mr. Baer added.

In early 2015, Amarantus reported data from a later study that showed a significant increase in the accuracy of MSPrecise when adding oligoclonal banding (OCB) to the algorithm. The company intends to publish data combining MSPrecise and OCB in the near future.

Gerald Commissiong, president and CEO of Amarantus Bioscience, said the company’s immediate focus is to conduct a CLIA-validation study in order to make the test commercially available. It also plans to conduct future investigational studies to determine whether MSPrecise scoring using NGS platforms can be utilized to identify clinically isolated syndrome patients who will convert to RRMS.

In addition, he said a more expansive clinical study with a larger patient cohort, including several sub-cohorts of RRMS patients on disease modifying therapies and OND patients, is also planned.

Canaccord Genuity and Roth Capital Partners have raised their price targets for LeMaitre Vascular (NASDAQ:LMAT) to $14.50 from $13, and to $14 from $11, respectively, after the company set another record sales quarter. The stock closed at $11.24 on Tuesday.

“We continue to view LeMaitre as one of the most undervalued small-cap stocks in med-tech, led by a prudent management team who continues to produce notable operating leverage as 14% operating margins in the second quarter were the second best ever,” writes Canaccord analyst Jason Mills.

The company has raised its 2015 revenue and operating income guidance to $77.3-million and $9.4-million, respectively, from $75-million and $8.2-million.

Roth analyst Chris Lewis said the second quarter marks another strong quarter for LeMaitre as it continues strong sales momentum and operating margin expansion.

“We come away incrementally confident LeMaitre can meet and potentially exceed its goal of 10% revenue growth and 20% income growth going forward and have increased our forward projections to reflect the strong first half performance,” he said.

Despite Lemaitre’s strong recent stock performance, he said the stock still currently trades at 2.4 times and 2.2 times projected 2015 and 2016 revenue, excluding cash, respectively, “representing a favorable long-term risk-reward profile.”

Roth Capital Partners has initiated coverage of Tracon Pharmaceuticals (NASDAQ:TCON) with a “buy” rating and $18 price target, calling the company an intriguing play in the $16-billion anti-VEGF market. The stock closed at $12.58 on Tuesday.

Tracon is developing an antibody targeting the endoglin receptor. Endoglin is essential to the process of new blood vessel formation, which is a commercially validated therapeutic target in oncology and AMD.

“We expect endoglin inhibition to have synergistic efficacy with pan-VEGF TKIs,” writes analyst Debjit Chattopadhyay. “Five mid-stage study readouts over the next six-to-12 months, if positive, could be a catalyst for the stock,” he added.

With clinical experience in over 300 patients, he said the company’s TRC105 drug candidate has shown good tolerability and promising anti-tumor activity in a range of solid tumors.

In patients refractory to VEGF inhibitors, a combination with TRC105 increases sensitivity, response rates, and has led to prolonged remissions, he added.

Novadaq Technologies (NASDAQ:NVDQ; TSX:NDQ) has posted revenue of $15.1-million for the second quarter, an increase of 35% from $11.2-million a year ago.

Product sales rose by $3.9-million, or 38%, primarily due to a 64% increase in recurring revenue and a 24% increase in capital sales.

“At the start of the year, we initiated our transformation from a company that was characterized by its partnership-based business model to one driven primarily by its own direct sales,” Arun Menawat, president and CEO, said in a statement.

“As demonstrated by our sales rebound in the second quarter, we were able to successfully navigate through a transitional first quarter and have begun to resume our strong growth trajectory,” he added.

The company estimates that the number of procedures performed using SPY technology systems during the second quarter was about 9,600, representing an increase of 30% year-over-year and 9% sequentially over the previous quarter.

Dipexium Pharmaceuticals (NASDAQ:DPRX) will present new Locilex microbiology data at the American Society for Microbiology’s Interscience Conference of Antimicrobial Agents and Chemotherapy and International Society of Chemotherapy’s International Congress of Chemotherapy and Infection (ICAAC/ICC 2015) scientific meeting in San Diego on Sept. 17-21.

Dipexium and its research collaborators will present data on pexiganan, the active pharmaceutical ingredient in Locilex, that highlight pexiganan’s activity against a broad spectrum of bacteria resistant to seven marketed or investigational topical antimicrobials.

After moving a novel omega-3 program through a successful Phase 2 program, Matinas BioPharma Holdings (OTCQB:MTNB) is now advancing two anti-infective drug candidates in the war against drug resistance.

Roelof Rongen

“Our initial focus is to take powerful, but sparingly used, anti-fungal and anti-bacterial drugs and increase their safety and potency,” president and CEO, Roelof Rongen, says in an interview with BioTuesdays.com.

Health authorities around the world have sounded the alarm on deadly, untreatable superbugs, which could kill more people than cancer by 2050. In the U.S. alone, more than two million people a year incur drug resistant infections and more than 23,000 die.

“Today, people can die from a drug resistant strain of strep throat,” Mr. Rongen points out.

The company’s lead program, MAT2203, is an oral formulation of Amphotericin B for serious fungal infections, which is scheduled to begin Phase 2a testing in collaboration with the NIH. MAT2501 is an oral formulation of amikacin for severe hospital-acquired bacterial infections, which is scheduled for an IND filing in the fourth quarter this year.

In June, Matinas reported data from a head-to-head study that showed its MAT9001, a prescription-only omega-3 fatty acid-based composition under development for the treatment of hypertriglyceridemia, demonstrated superiority against Vascepa in reducing lipids, triglycerides, apolipoproteins and PCSK9 levels.

“The regulatory environment for the development of anti-infectives is much more conducive for an early-stage biotechnology company, given the tremendous unmet medical need and governmental support and incentives,” Mr. Rongen says.

“The omega-3 cardiovascular space is a much more typical regulatory environment with regulators carefully managing risks versus benefits, as we saw with the FDA’s decision in 2013 against expanding the approved use of Amarin Pharmaceuticals’ Vascepa.”

Mr. Rongen explains that MAT9001 is a next generation omega-3 fatty acid composition of docosapentaenoic acid (DPA), which has a unique mechanism of action and is highly potent.

“DPA differentiates MAT9001 from other omega-3 fatty acids,” he contends. “It has the potential to expand and greatly improve therapeutic options for patients with high triglyceride and cholesterol levels in the fight against cardiovascular disease.”

He says Matinas plans to explore partnership opportunities for MAT9001. “Given the strong data and unique orally available PCSK9-effect, we believe MAT9001 will benefit from further development in a partnership context.”

According to Mr. Rongen, anti-infectives are the core of the company’s future. “Our technology potential in this space is highly significant and should benefit from a favorable regulatory and government environment.”

Among other things, he notes that Congressional initiatives have included additional budgetary funding for anti-infective drug development, largely through the NIH, and the potential to seek Qualified Infectious Disease Product (QIDP) designation. QIDP designation makes anti-infective drug candidates eligible for fast track status, priority review, and a five-year extension of market exclusivity.

In addition, the NIH is offering Small Business Innovation Research grants and research contracts for anti-infective drug development.

Mr. Rongen explains that Matinas and the NIH are working together to develop oral cochleates, which are solid lipid particles that trap toxic drugs and deliver their payload to infected tissues, increasing their potency and eliminating toxicity. The company’s cochleate lipid delivery portfolio is under an exclusive license from Rutgers University.

“As a novel lipid-crystal nano-particle delivered formulation of amphotericin B, MAT2203 has the potential to be a groundbreaking advancement in anti-fungal treatment,” he contends.

Amphotericin B is the anti-fungal of choice for immuno-compromised patients. While it is an effective killing-agent, it has the potential for significant toxicity, including a high risk of liver and kidney damage. Despite limitations in its use, the global market for amphotericin B is about $700-million.

Mr. Rongen points out that Matinas’ oral formulation has significant advantages over current IV-only administration of amphotericin B, including efficacy and little-to-no kidney toxicity in animal models, compared with current amphotericin B therapy.

“This differentiation supports the potential to capture and expand the $700-million global amphotericin B market,” he says, adding that the safety and tolerability of MAT2203 also have been demonstrated in a Phase 1 human study.

The treatment protocol for a Phase 2a study in patients with refractory mucosal fungal infections is under final review in collaboration with NIH, which will conduct and pay for the study. The study is expected to begin in the current quarter, with data expected in the first quarter of 2016, or earlier under certain circumstances.

Matinas and the NIH are collaborating to develop oral cochleates, a groundbreaking advancement in anti-fungal treatment that traps toxic drugs while delivering their payload to infected tissues

If the data is positive, Matinas plans to engage with the FDA and propose and agree on the details of the further development program for MAT2203.

The company is also developing MAT2501 with the same technology to deliver amikacin in an oral lipid-crystal nano-particle cochleate formulation. Amikacin is a very potent gram-negative aminoglycoside antibiotic. It is administered intravenously but also has been linked to significant side effects.

Of the two million people annually in the U.S. who acquire serious infections that are resistant to one or more antibiotics, about 700,000 are gram-negative infections, such as pseudomonas lung infections, hospital-acquired bacterial infections and sexually transmitted diseases, including gonorrhea.

According to Mr. Rongen, gram-negative bacterial infections are characterized as the No. 1 unmet medical need of infectious disease specialists. Effective first-line treatment of serious infections requires use of broad-spectrum antibiotics, with activity against a broad range of bacteria. However, many strains of bacteria have mutated over time, developing resistance to existing drugs.

MAT2501 has demonstrated efficacy in proof-of-concept testing in animal models. He says formal preclinical animal toxicology studies are ongoing at the NIH in preparation for an IND filing later this year and clinical trials in 2016.

“MAT2501 has the potential to be the first orally administered amikacin formulation without toxicity or side effects seen with IV treatment,” he contends.

Mr. Rongen notes that the cochleate portfolio is covered by 17 issued patents, with protection extending through 2027, as well as 20 pending U.S. and foreign patents, which would extend protection through 2033.

At the end of June, Maxim Group analyst, Jason McCarthy, initiated coverage of Matinas with a “buy” rating and price target of $6, saying that with its current low valuation and potentially disruptive technology, “we see an opportunity in Matinas for investors.” The stock closed at 92 cents on Friday.

“Better delivery, no toxicity and oral pills could translate into more physician use and thus significant revenue opportunity,” he said.

The National Institute of Allergy and Infectious Diseases, one of the centers within the NIH conducted the study.

Ciclofilin’s CPI-431-32 is a proprietary cyclophilin inhibiting molecule that targets the host, but does not directly target the virus. As a result, CPI-431-32 inhibits the virus’ ability to hijack the host for propagation.

Multiple modes of activity against the HBV life cycle have already been demonstrated for CPI-431-32, utilizing in vitro assays conducted both in-house and in collaboration with Dr. Philippe Gallay of the Scripps Research Institute in San Diego and with partial support of the National Research Council of Canada.

The NIH/NIAID findings confirm that one of the important post-entry mechanisms blocked by CPI-431-32 is viral replication within the liver. The company previously disclosed the drug’s anti-fibrotic effect. The drug also appeared to be well tolerated.

“We continue to be very encouraged by test results for CPI-431-32,” Dr. Robert Foster, CEO, said in a statement, adding that the drug has demonstrated multiple modes of activity including, blockade of viral entry into hepatocytes and a reduction of HBV replication.

“We fully anticipate that this drug will continue to display additional modes of activity as further testing is carried out,” he added. “Taken together, we believe CPI-431-32 will diminish the virus’ ability to propagate while mitigating the downstream negative clinical sequelae observed in hepatitis patients.”

Dr. Gallay said the recent data indicate that CPI-431-32 will not only inhibit viral replication, as confirmed with the NIH/NIAID study, but may also suppress expression of certain proteins, including HBsAg, HBx, and may further reduce the formation and stability of cccDNA.

Titan Pharmaceuticals (OTCQB:TTNP) will ask shareholders at the annual meeting on Aug. 24 for approval of a reverse stock split within the range of 1-for-3 and 1-for-8 at any time prior to June 30, 2016.

“We believe that enabling our board to set the ratio within the stated range will provide us with the flexibility to implement the reverse split in a manner designed to maximize the anticipated benefits for our stockholders, including a potential listing on a national securities exchange,” the company said in proxy material for the annual meeting.

Titan said it has applied for listing on the NASDAQ Stock Market. The initial listing criterion for NASDAQ’s Capital Market is a minimum closing price of $3. Shares of Titan closed at 82 cents on Friday.

“Our goal, through the reverse split, is to increase our stock price so that it enables us to satisfy the NASDAQ listing standards,” Titan said. “We also believe that a higher stock price will make our company more attractive to a broader range of investors, including professional investors, institutional investors and the general investing public.”